Definition: To Identify Stones, Tumors, Or Narrowing In The Biliary Tree.
| Device Type ID | 2071 |
| Device Name | Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula |
| Physical State | Catheter. May Include Radiopaque Markings |
| Technical Method | Passed Through An Endoscope (duodenoscope) Into The Biliary Duct To Inject X-ray Contract Media Into The Biliary Tree. |
| Target Area | Biliary Tree |
| Regulation Description | Endoscope And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Renal Devices Branch (RNDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ODD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2071 |
| Device | Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula |
| Product Code | ODD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COOK ENDOSCOPY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WILSON COOK MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 7 |
| Total Device Problems | 7 |